OptiBreech 1, v 1.1
Research type
Research Study
Full title
The OptiBreech care pathway: evaluating the feasibility and acceptability of team care for women seeking to plan a vaginal breech birth
IRAS ID
268668
Contact name
Shawn Walker
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
Research Summary
Why? Most babies are born head-first, but about 1 in 25 are bottom-down (breech) after 37 weeks of pregnancy. Women who wish to plan a vaginal breech birth have asked for more reliable support from an experienced professional. This aligns with national policy to enable maternal choice.
What? In this study, we are exploring the feasibility of evaluating a new care pathway for women with a breech pregnancy. OptiBreech care includes specialist leadership, evidence-based training, and an active birth approach if a vaginal birth is planned.
We do not know whether the OptiBreech care pathway will be safer and/or as cost-effective as standard care. One way to find out is by comparing outcomes within each pathway in a clinical trial. Some important questions must be answered first to design a successful large-scale trial. This is called a ‘feasibility study.’
Who? Women with a breech pregnancy after 37 weeks who choose to plan a vaginal breech birth within their current Trust guidelines will be eligible to participate. They will be offered care from an experienced team with enhanced training.
How? We will follow the outcomes of women and babies. We will also interview them and the staff who care for them about their experiences. We will use routine data, interviews and surveys to determine:
• Are Trusts able to implement the OptiBreech care pathway?
• How much time does it take to develop a proficient team to deliver the service?
• How do women and staff feel about OptiBreech care?
• What adjustments might need to be made to the OptiBreech care pathway to make it feasible to deliver within the NHS?Where? At least 12 sites from across the UK will participate. The observational study will last for 2.5 years.
Summary of Results
The research team would like to thank the women and healthcare professionals who participated in the OptiBreech 1 study. We hope that the results will help to improve care for the population of women seeking to give birth to their breech-presenting (bottom-down, head-up) babies vaginally at term, as well as those who experience an unexpected breech birth.
The full study title was, “The OptiBreech Care Pathway: evaluating the feasibility and acceptability of team care for women seeking to plan a vaginal breech birth.” The research was sponsored by King’s College London and funded by the National Institute for Health Research, through an Advanced Fellowship held by Dr Shawn Walker. Dr Walker is a post-doctoral researcher and a consultant midwife. She is also a co-director of Breech Birth Network, a community interest company that provides vaginal breech birth training.
The OptiBreech 1 study was the first stage in the OptiBreech programme of research. Our ultimate aim is to test new methods of managing breech pregnancies and births, which may improve the experience and safety of these births. These new methods are described as physiological breech birth (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbecJlKxVMe5W0ew4J-2BRYk6GF2jsA57oyb1M4VugzLX39Ndx2Y3y4X68dhVwCCZbGlHJF391Qa-2Fros1-2Fvonz21cUm36RKlexM1eSL96l2ccXcdFeL_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhXCt5N2YKPuatPG3dDynfbRcCjwb47-2BnKqArMwKejJ7dtv-2BRN0GG-2B9sNqKHKjrSWMj8xpmqIi9Xn14lgAmKVJvDVBEZlRhAVsZFNwhw1URH-2BUJ1MFSzwLCIpCEDNGUx4D1hslXmA3P63fMcsTHV3BurHyJSSkimmxJS7l7b4iVQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C9766007455314606685708da9cb36eb4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637994591699940502%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=XXCClQa8DiVGY2mk%2FwPxgb7%2Fuw6V%2FcewD2gskSwxFgo%3D&reserved=0 We first needed to determine if it was possible to provide these new methods in practice, from a team with enhanced training and experience. The purpose of the OptiBreech 1 study was to determine whether it was possible to provide team care for women requesting support for vaginal breech births and whether this model of care was acceptable to women and staff.
We involved service users in the design and interpretation of the research (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbYKtBFt8qpf9jJiLi-2FS2rSPhx6fR9cfMj7uYhkDQJrHXOguj_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhXCt5N2YKPuatPG3dDynfJ9KdadNIlETxdZOgjTYPygsyt1G-2FgbnjApxMeQXd2TPaaxgJv4Dj2MzKezMKMg7YaXU0PH0BzoMT9tjuewiWQhzndOQBmlXMOQz62Si7BSkMDSQZwmWUoBLHVEeQNENR3naPOm-2Fb5e3ZYdR2OoU2Gg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C9766007455314606685708da9cb36eb4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637994591699940502%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=TUFkaGCVDdKyVlfxPD4gCzUVkQiqm8yHnkwVO4zaWeY%3D&reserved=0 We have an active OptiBreech Public Involvement and Engagement group, including a closed Facebook group for women and staff who have participated in the research. We also involved three service users as members of our research team. This included women who have experience of straightforward vaginal breech birth, and women who have experienced complications of both vaginal and caesarean births.
This research was needed because babies that are in a breech position at the end of pregnancy are at additional risk, regardless of the mode of birth. Vaginal births carry an additional small increase in risk compared to caesarean births for breech babies. However, not all breech births can be prevented, and unplanned vaginal births where the baby is only discovered to be breech at the end of labour may have additional risks. We may be able to reduce this risk using team care and physiological breech birth methods, but we cannot recommend changes in practice until we know whether they will improve outcomes.
At the same time, evidence about women’s experiences indicates that a significant minority of women, after considering all potential risks and benefits, would like to plan a vaginal breech birth. These women almost universally find it difficult to access support for this option and feel they have no choice but to accept a caesarean birth. This situation goes against national guidelines and the ethical principles of informed decision-making in the United Kingdom. Over-reliance on caesarean births in less resource-rich settings results in many more adverse outcomes for women, in addition to a lack of choice. The OptiBreech programme of research is designed around the idea that, by supporting women who are actively seeking support for a vaginal breech birth to have one, we can learn more about how to make breech pregnancies safer for all women.
The OptiBreech 1 study took place from January 2021 – June 2022 in thirteen different NHS hospitals across England and Wales. The study ended a year early because there had already been enough participants for us to meet our primary aims by June 2022, and the next stage of research was already underway.A total of 82 women planned a vaginal breech birth within the OptiBreech 1 study. Sixteen (20%) of these participants sought out participation in the study and transferred their care from another hospital to access it, due to a perceived lack of skill or support at their booking hospital. The participants received counselling to plan their birth from a member of the OptiBreech team who had completed the physiological breech birth training. Then, the team put a plan in place so that someone who had completed the training and, ideally, had significant experience (>10 births attended, teaching experience) would be at the birth.
A total of 43 (52%) women had vaginal births after planning a vaginal breech birth. 38 women (46%) had a vaginal breech birth, 2 (2%) had a breech birth with forceps, and 3 babies (4%) were born head-first after turning themselves in late pregnancy. 16 women (20%) had a planned caesarean birth and 23 women (28%) had an in-labour caesarean birth.
We measured how often the 40 vaginal breech births were attended by someone with full OptiBreech training. A total of 35/40 (88%) were attended by someone who had completed training. In 2 cases, no attempt was made to call an OptiBreech team member. In the other 3, the births happened too quickly for the OptiBreech team member to attend. Births were attended by someone who met criteria for advanced proficiency 68% (27/40) of the time. To achieve this, OptiBreech team members spent an average of 3.38 days and 6.49 nights on call per birth.
We measured how often births were managed in line with key principles of physiological breech birth. In 30/39 births (77%) we have information on, the woman gave birth in an upright position, eg. kneeling or hands/knees. In 34/39 births (87%), women were encouraged to change position and/or actively push to quicken the end of the birth, before anyone used hands-on interventions to help the baby out. In 34/39 births (87%), the birth was complete within five minutes of the birth of the baby’s pelvis, as recommended.
One thing that teams had difficulty achieving was keeping the umbilical cord connected to the placenta if the baby needed help to start breathing immediately after the birth. Our OptiBreech Involvement Group told us this was important to them, and women we interviewed said that it was disappointing when teams did not achieve this. We have therefore made it a priority to learn how we can help teams to do this better in the next stage of OptiBreech research.
A total of 4/82 (5%) babies in this study were admitted to the neonatal intensive care unit. This is similar to the national average for all babies born after 37 weeks of pregnancy. One baby had a severe adverse outcome (1/82, 1.2%); this was reported to the Study Steering Committee, the Sponsor and the Research Ethics Committee, in line with the research protocol. This rate is similar to other studies of outcomes following vaginal breech birth. For example, in the PREMODA study (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbfkWri2UJqqh8AUR9C-2FAgAw7bZx2-2FSUJnmVGz-2FCo3aQvDv9YyCM7gAflBwr5O6NzR-2FyOAMzGYO16X8UozFi8tD0-3D6MLy_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhXCt5N2YKPuatPG3dDynf864Ek-2BfDN1R5P9NOWG88RUXE9XPQEg-2BTzwEgQ3MhMF1jy3fRAPOkD9NqGiZVl-2BmUAwUEKYwEj9fDYnvjYCxckRphyAp5fIc6xDqZhUYJoEcgrEvrJ8scYcrtYLzutyZSs5X8BePyy-2Fp7GV-2FWxqgEbQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C9766007455314606685708da9cb36eb4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637994591699940502%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=5%2BWCtTqTOJ2aEGbiVTYH06vxdzbmKUklMukj4wZxmgE%3D&reserved=0 1.6% of all breech babies born after both planned vaginal birth and planned caesarean birth had serious adverse outcomes. Our purpose in this study was not to assess the outcomes of vaginal breech birth, but these outcomes are reassuring that it is safe to continue with further research.
Our research team also interviewed 20 women who planned vaginal breech births, from different hospitals, with different outcomes (vaginal breech birth, caesarean birth, neonatal admission, etc.). From these interviews, we identified three important needs for breech care in late pregnancy. Meeting these needs made care acceptable to women and led to higher recruitment rates in our study. These were: balanced information, access to skilled breech birth care, and shared responsibility. Women found dedicated clinics and breech specialists (including midwives and obstetricians) more acceptable than the care they encountered outside of these settings. We have presented early and final results at two conferences (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbTj6I4LoaySNL6OM9P2aFdNJKO9oaClwR38Jc0DvCpiOHIgJgtwOYHC7WzltfLWE3A-3D-3D6xUX_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhXCt5N2YKPuatPG3dDynfy0ndr5JAXVZ3sSb0DlkgmJb3MesX5PtEirh6QJuSlh-2BmjBVwXOoa28hrdy7B4g-2FyFcOVq3IKbe8pNvkHA380sL-2BR-2BTOVxLV0BVHOnLaIfcJCQS-2FqHi3pRIMMEBS2KmlTe0N9i-2BF2otSdmVje8IX3DQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C9766007455314606685708da9cb36eb4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637994591699940502%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=FH523TxZTi%2Fad6l3riViqYQorrNJi29aLMzXOGNDig4%3D&reserved=0 submitted a paper for publication and shared the results with participants.
We also interviewed 21 staff members involved with the OptiBreech study, from different hospitals and professions (midwives and obstetricians). These interviews are still being analysed by the research team, to identify factors that help and hinder team care for vaginal breech births.
The results of this study have helped us design further research about the OptiBreech model. We understand a lot more about what ‘good’ care looks like for women who want to plan a vaginal breech birth, and what is required of maternity services to deliver this care. In the next stage of the research, we hope to look at the outcomes for more babies following physiological breech births. This will require at least 365 participants. We will then be much more confident about the safety results, and these can be used to help women make decisions about how they would like to give birth to their breech babies. The results will also help to improve training for health care professionals.
The learning from OptiBreech 1 has also contributed to a toolkit for other services that wish to deliver care in dedicated clinics with specialist midwives, to improve the experience of care for women whose babies are in a breech position at the end of pregnancy (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRO8u8LqWBHlLaWwoHiXxW7xIHk9QuvNBdWyRS5BHWZK54JFT9F50t5W1AtE5GWL7RxurbVPsWCp8HmxcMNy2JBwyTSpidP-2Fj1EmaGX2vWJYw4Zy_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhXCt5N2YKPuatPG3dDynfkXkov-2BQr-2FwUQMDOtLSNYqCypCoyjAt-2FUC5DErLDyUPPIXJN5svug8vSs5SiCKXlal5tG9B5GeLVWdjxckPND5-2FpeoP-2FEuVsoACBqjpExtjzGiX52bBsOb3PHfet1eLQGM3w5fqzfnIo96821loauKw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C9766007455314606685708da9cb36eb4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637994591699940502%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=8HwNmtM2KLLbvsRDuw6X6Tkj4wldFR%2BwZpgmT2RCzII%3D&reserved=0
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0287
Date of REC Opinion
6 Jan 2021
REC opinion
Further Information Favourable Opinion